Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis

Part of paid clinical trials in Ocala, Florida.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02905331
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — DRUG
    Participants will receive 100 mg of Guselkumab as 100 mg/mL solution via SelfDose device.
  • Placebo — DRUG
    Participants will receive matching placebo supplied in a PFS assembled in a SelfDose device.

Study Details

The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in participants with moderate to severe plaque-type psoriasis.

Key Dates

Start date
Feb 28, 2017
Status verified
Jan 2025
Primary completion
Feb 6, 2018
Completion
Feb 6, 2018

Study Design

Enrollment
78 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 (Guselkumab: Placebo)
    Participants will receive 100 milligram (mg) guselkumab administered as a 100 milligram per milliliter (mg/mL) solution in a single-use prefilled syringe (PFS) assembled in a SelfDose device at Weeks 0, 4, 12, 20, and 28; liquid placebo for guselkumab 100 mg at Week 16 to maintain the study blind.
  • Experimental: Group 2 (Placebo: Guselkumab)
    Partcipants will receive placebo at Weeks 0, 4, and 12 followed by guselkumab 100 mg at Weeks 16, 20, and 28.

Primary Outcome Measure

Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 [ Time Frame: Week 16 ]

Locations (8)

FacilityCityStateZIPSite coordinators
Renstar Medical ResearchOcalaFlorida34470-
Arlington DermatologyRolling MeadowsIllinois60008-
Indiana Clinical Trial CenterPlainfieldIndiana46168-
Dermatology SpecialistsLouisvilleKentucky40241-
Hamzavi DermatologyFort GratiotMichigan48059-
University of Pittsburgh Department of DermatologyPittsburghPennsylvania15213-
Clinical PartnersJohnstonRhode Island02919-
Virginia Clinical ResearchNorfolkVirginia23502-

Find similar trials in Ocala, FL

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Renstar Medical Research· Ocala, FLArlington Dermatology· Rolling Meadows, ILIndiana Clinical Trial Center· Plainfield, INDermatology Specialists· Louisville, KYHamzavi Dermatology· Fort Gratiot, MIUniversity of Pittsburgh Department of Dermatology· Pittsburgh, PA

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